NCT05834387

Brief Summary

This study investigated the impact of the establishment and application of the "health care-family-environment" linkage mechanism on the level of migration stress, coping styles and care satisfaction of families of patients transferred from the EICU, in order to provide a reference for improving the physical and psychological health of families and to promote the role of family members in the social support of patients transferred out of this category.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

April 11, 2023

Last Update Submit

July 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stress assessment

    Stress assessment assessed by ICU Transfer Stress Assessment Scale for Families of Patients Transferring Out

    48 hours

Study Arms (2)

Control group

EXPERIMENTAL
Procedure: EICU Transfer Routine Care

Experimental group

EXPERIMENTAL
Procedure: Implementing interventions based on a 'health care-family-environment' linkage

Interventions

EICU Transfer Routine Care

Control group

Nursing interventions in the experimental group The interventions were based on the "health care-family-environment" linkage

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Family members of trauma patients scheduled to be transferred from the EICU to a general unit within 24h;
  • Family members of patients aged ≥ 18 years;
  • Family members who are responsible for the main care tasks and medical decisions of the patient during hospitalisation;
  • Family members of patients with clear language and good communication skills;
  • Families of patients who volunteered to participate in this study.

You may not qualify if:

  • Family members of patients temporarily transferred out of the EICU or temporarily discharged from trauma
  • Families of patients who voluntarily request termination of treatment;
  • Family members of patients with cognitive impairment, speech impairment or mental abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zunyi Medical College

Zunyi, Guizhou, 563000, China

RECRUITING

Study Officials

  • Xu Ren

    Zunyi Medical College

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

April 11, 2023

First Posted

April 28, 2023

Study Start

May 1, 2023

Primary Completion

November 1, 2023

Study Completion

May 1, 2024

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations